MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3.0X130MM FIBULA NAIL, LEFT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that upon doing the initial 3.0 reaming over the flexible guide pin, the tip of the guide pin broke off in the proximal fibula.This wasn't noticed on x-ray until the implant was fixated and final x-rays were taken.The pin was pushed further up the fibula during implantation.The doctor did not want to leave the broken pin in the bone and chose to remove the hardware.In order to do so, a proximal drill hole was made at the distal end of the pin to remove the pin.This took some time.Once removed, the current nail implant was inserted to be re-implanted.The proximal talons were attempted to deploy but bone debris or something was causing the nut to not fully push out the talons.This implant was removed and another fibulock implant was opened to complete the case.Two extra incisions were made in this case because of the hardware removal.One as mentioned in the proximal fibula and the second in the medial tibia to remove the syndesmosis button.Additional information provided 1/8/2021: procedure was a fibula orif with syndesmosis.

• Brand Name: 3.0X130MM FIBULA NAIL, LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11186476
• Report Number: 1220246-2021-02482
• Device Sequence Number: 767029
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 10422552
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other